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临床试验/NCT03926689
NCT03926689已完成不适用

Evaluating the Impact of Sending SMS Messages to Increase Egg Consumption Among Children One 1-2 Years of Age, a Cluster-randomized Controlled Trial in Kanchanpur, Nepal

Helen Keller International1 个研究点 分布在 1 个国家目标入组 3,301 人开始时间: 2019年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,301
试验地点
1
主要终点
Child minimum dietary diversity

研究概览

简要总结

Eggs are well-known to be a balanced source of protein, energy, fatty acids, and micronutrients and increasingly identified as an opportunity to improve nutrition of poor populations. Few implementation studies have been done globally, and none in South Asia, to assess the effectiveness of using behavior change programs to motivate households to increase egg consumption. Egg consumption is particularly poor in Nepal, but the government and development partners are implementing at scale policies and programs to address poor diets and other determinants of undernutrition, which is persistently high in Nepal.

This cluster-randomized controlled trial (c-RCT) aims to help address the gap in the evidence base regarding how to improve egg consumption. The c-RCT will evaluate the effectiveness of using short message service (SMS) messaging, layered into a large-scale behavior change program, to improve egg consumption and dietary diversity among children 1 to 2 years of age. A two-arm trial will be used to compare the following two strategies: 1) Suaahara II standard multi-sectoral nutrition interventions without any text messages and 2) Suaahara II standard multi sectoral nutrition interventions plus a SMS message campaign targeting all adult household members of households in the 1000-day period between conception and a child's second birthday.

详细描述

Eggs are well-known to be a balanced source of protein, energy, fatty acids, and micronutrients and increasingly identified as an opportunity to improve nutrition of poor populations. A recent trial in Ecuador showed dramatic improvements in child growth after consumption of eggs for only six months. This efficacy trial also showed that culturally appropriate strategies, taking local norms, values, and expectations into account, are important. Furthermore, small-scale egg production has proven to be an effective intervention to increase egg consumption among children. Few implementation studies have been done globally, and none in South Asia, to assess the effectiveness of using behavior change programs to motivate households to increase egg consumption.

Despite significant reductions in under-nutrition over the last several decades, Nepal persists as a nation with one of the highest prevalence of child undernutrition globally. There is substantial room for improvement in important nutrition-related behaviors, including poor diets. According to the 2016 Nepal Demographic and Health Survey (DHS), only about one-third of children 6 to 23 months of age receive a minimum acceptable diet, less than half (47%) eat foods from at least 4 of 7 food groups to attain minimum dietary diversity (DD), and not even 10% consume eggs. The Government of Nepal (GoN) and development partners have prioritized multi-sectoral (integrated) nutrition as a key development agenda. Suaahara II, a USAID-funded program (2016-2021), aims to reduce under-nutrition particularly among women and children in the 1000-day period between conception and a child's second birthday, a crucial window of opportunity during which interventions have optimal impact on child growth and development. Operational in 42 of Nepal's 77 districts, Suaahara II uses a district-wide approach and interventions cover nutrition, health, family planning, agriculture, governance, gender equality, and social inclusion.

Suaahara II's social and behavioral change communication (SBCC) interventions, using lessons learned from the first phase of Suaahara, prioritize 10 key behaviors for which knowledge-to-practice gaps persisted at the end of Suaahara I. Two of these 10 behaviors focus on dietary diversity: 1) mothers should eat a diverse diet, including eggs and meat, and 2) young children should eat a diverse diet, including eggs and meat. Suaahara II's SBCC approach includes a combination of interpersonal communication (IPC) (e.g., home visits for 1:1 counselling with Suaahara II frontline workers); community mobilization (e.g., health mothers group meetings; food demonstrations and key life event celebrations); mass media (i.e., an interactive weekly radio program known as Bhanchhin Aama); and as of 2018, a series of 35 SMS messages sent to 1000-day households (other than those residing in Kanchanpur, the trial district) to reinforce the promoted 10 key behaviors as well as regular contact with the health system.

The SMS messages started after monitoring data showed that over 95% of beneficiary households own a phone, including more than two-thirds of mothers. Each message is sent at a specific time to align with key times when a key nutrition-related health service contact point or important nutrition-related practice is needed during the 1000-day period (e.g., a reminder to go for antenatal care; an encouragement to continue exclusive breastfeeding for another two months when the child is 4 months). In pre-testing of this intervention in 2 districts with 1000-day mothers, Suaahara II found acceptability and interest to be high and a preference for text over voice messages as mothers noted that they can keep the former as record and messages were read when they had time providing them with flexibility; messaging could be as often as weekly; and mothers showed the messages to others and discussed about the content, even though not prompted to do so. The cost of sending SMS messages in Nepal is also lower than other behavior change methods which include costs for staff, travel, jobaids, and so on. For these reasons, SMS push-messaging has potential to be an effective tool for behavior change. Evidence of intervention effectiveness is lacking, however, and is particularly needed in Nepal where the Ministry of Health and Population is prioritizing the use of SMS push messages as part of their SBCC strategy for implementation of the Multi-sectoral Nutrition Plan.

While SMS messaging is promising, various mHealth, and more recently mNutrition, literature reviews have noted the lack of rigorous research designs to assess effectiveness of these interventions. Some mHealth studies have shown positive results; for example, in Zanzibar a trial showed that mobile messaging can improve antenatal care attendance. These studies are few, and mNutrition studies even fewer. To the investigator's knowledge, no studies have assessed the effectiveness of using mNutrition interventions to improve diets in South Asia. Recent formative research in Sri Lanka, however, suggests the potential effectiveness of using mobile phones to improve infant and young child feeding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • household must have resided in the study cluster for the previous 12 months;
  • household must have at least 1 child 12-23 completed months of age who was not acutely ill the previous day and does not have a disability preventing normal feeding; if a household has more than one child aged 12-23 months, but the children have different mothers, each mother is an eligible trial participant
  • household must have at least one adult (18 years or older) residing in the household and owning a mobile phone
  • household must be able and willing to register the phone number for the intervention and consent to inclusion in the survey for the trial.

排除标准

  • a few clusters will be excluded from the study given their lack of representation of the overall study area (e.g., 2 clusters with less than 150 households which are all landless and without government resources; 1 cluster which is exclusively a Tamang population; and 1 cluster which is the main urban area)
  • in the rare occurrence that in an eligible household, a mother has more than one child aged 12-23.9 months, then the youngest will be chosen in the trial and the other child excluded

结局指标

主要结局

Child minimum dietary diversity

时间窗: baseline and 12 months later

Change in prevalence of obtaining minimum dietary diversity score (at least four of seven food groups) in previous 24 hours for children aged 12-23 months of age

Child egg consumption

时间窗: baseline and 12 months later

Change in prevalence of any egg consumption in 24 hours prior to survey among children 12 to 23 months of age.

次要结局

  • Adult minimum dietary diversity(baseline and 12 months later)
  • Adult dietary diversity score(baseline and 12 months later)
  • Infant and Young Child Feeding knowledge(baseline and 12 months later)
  • Adult Bhanchhin Aama listenership(baseline and 12 months later)
  • Child dietary diversity score(baseline and 12 months later)
  • Adult caregiver egg consumption(baseline and 12 months later)
  • Adult Bhanchhin Aama listenership frequency(baseline and 12 months later)
  • Health Mothers' Groups participation(baseline and 12 months later)
  • Health Mothers' Groups participation frequency(baseline and 12 months later)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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